The senators urged FDA to begin work on a new draft that provides needed clarification on what constitutes a New Dietary Ingredient (NDI)—but, in their words, does not undermine Congress’s desire to provide consumers with access to safe, affordable dietary supplement products. Exactly!

These senators were uniquely qualified to make such a request, since they were the principal authors of DSHEA, the Dietary Supplement Health and Education Act of 1994. “When Congress included language in the Food Safety Modernization Act (FSMA) directing FDA to clarify when a dietary supplement ingredient is a new dietary ingredient, the expectation was that the guidance would be consistent with DSHEA,” they write. “Unfortunately, the draft guidance serves to undermine DSHEA in a number of important respects.”

They go on to outline the various arguments that we have been making in these pages for some time:

The requirement for a manufacturer to submit an NDI notification for every dietary supplement containing an NDI is directly contrary to the language of DSHEA, which requires notification only of the intent to use an NDI;

This new requirement is burdensome and would impose substantial additional costs on manufacturers, would not provide additional safety benefits, and would undermine access to the safe, affordable nutritional supplements that DSHEA was designed to ensure;

The NDI guidance’s assertion that synthetic copies of ingredients can never be a dietary ingredient is without any statutory basis, and is contrary to longstanding FDA policy; and

This guidance is contrary to Congressional intent by grandfathering in only ingredients that were marketed before the enactment of DSHEA—such an argument is particularly specious since “the term dietary supplement wasn’t even defined prior to DSHEA”!

The senators requested that FDA meet with interested parties to work through all of the issues raised in our and others’ comments. Fortunately, FDA can’t just ignore the senators’ request, because the agency is required to work within legislative intent. Otherwise they would be creating new law—which legally they cannot do. This is one of the arguments we have been making all along—that FDA is in fact making new law with this draft guidance, and now Congress is calling them on it!

We would like to thank Senators Harkin and Hatch for being such stalwart champions of natural health, and for their leadership in this battle to prevent the FDA from usurping powers that they are not legally entitled to. We also want to thank every one of you for contacting Congress and the FDA and being such a vital part of this process.

We aren’t out of the woods yet—we’ll have another update soon with additional action items for you. The time may come for more specific legislative action, and we may find ourselves battling FDA in the courts as well. That’s why your continued support and activism is so terribly important. Together we can win this one, preserve your access to supplements, and keep supplements from costing as much as drugs.

106 Responses to “Senators Give Supplements a Lifeline”

I support the more conservative approach to reining in new dietary supplements. Without evidence showing their effectiveness, they may benefit the manufacturers and no one else. They may, in fact, be harmful.

I applaud Senators Hatch and Harkin for calling attention to the bureaucratic shroud the FDA has imposed on dietary supplements. Consumers would be best served if FDA spent more time enforcing the current laws rather than attempting to reinterpret and circumvent those laws in order to create a void in the dietary supplement market — to be filled by pharmaceutical companies!

I was sick alot, I got off of 4 medications fore asthma.
Today I am doing well , do to the help of supplements and vitamins.
My Thanks to the creators. Thank God.
Sens. Harkins & Hatch Thank you & God Bless.

The FDA is a tool of Big Pharma and the AMA. The American people want to use natural healing methods including dietary supplements. The idea that only drugs can cure disease is false, and everyone but Big Pharma and the FDA knows this fact.

The supposed guardians of our freedoms and those who look out for the “little guy” do just the opposite. This perfectly makes the case for a very limited government, which our Founding Fathers wisely encoded in the Constitution. Let’s start electing people who will govern and appoint judges who hold to a strict, literal reading of the Constitution instead of becoming dictators. Elections matter folks!!!

Thanks for the feedback as to the effect of our efforts. Keep me posted and let me know if you need any help from me. Would a request for a cash contribution from members to sustain this effort be beneficial?

THANK YOU for not only being open minded, forthright, and logical but showing the population that their open does matter and can be heard.

Many people heard about the FDA’s criminal actions but REFUSED to join the fight. I hope this will motivate other to get involved on all the other serious health issues that the FDA is seeking totalitarian control over!

The FDA (Food & Death Administration) absolutely MUST be dismantled!!!!
I say *KUDOS* to Senator Harkin and Senator Hatch for going to bat for the supplement industry, and of course all the effort and hard work the ANH-USA has done and with so many accomplishments on so many health issues Americans are faced with today. I am proud to be a supplement supporter and user!
Thank You!!!!

Thank you Senators HATCH and HARKIN for standing up for the American people and protecting our freedom to utilize the dietary supplements of our choice! Congressmen WAXMAN and Senator DURBIN who have both worked steadfastly to kill the availability of supplements need to take lessons from you guys. Perhaps they got confused and thought they were elected to represent BIG PHARMA.

Last but not least, Kudos to ANH for taking action to stop this threat to our health and our freedom of choice! Good work!

Good work. Next I ask you this… supplements in the form of plants have been used for thousands of years. There should be no hinderances placed on putting them in bottles or mixing them in a variety of combinations. This would basically be illegalizing food/nourishment. Additionally, the nutritional field is young, much is not known, so the bill now limits new discoveries, this has never been placed on any other industry (though many industries/products should have been regulated per they destroy the environment which provides life, liberty and the pursuit of happiness, in trade of INC profit and payola by lobbyists). Thanks for all your efforts to protect our food, bottled or otherwise.

Way to go Sens Harkin/Hatch and ANH!!! I know we’ll win this battle and war. May 2012 be
the year of awakening for everybody, so they realize the benefits of natural supplements, vitamins and organic foods.

I would like to see someone look into Commissioner Hamburg’s motivation behind this and other activities. It is clear there is a war on supplements. Does someone just wake up one day and decide they are bad? What recourse do citizens have to call into question what motivators come into play with actions like this. It appears reform is needed at the FDA to return it to an unbiased position.

thank you ANH so much for all that you do! You are so important and so good….
Thank you Hatch and Harkin! We so much appreciate your humanely-oriented work in this matter!

Why the need to re-evaluate wording? Why any need to review NDIs at all? Herbs and foods have been around for milennia and have already stood the test of time. Clinical testing is already being done a-plenty on herbs and supplements. there is no need for further controls.

I suggest that we won’t have our freedom back unless some of us in the public run for public office to challenge congressional seats. When we get enough good people in office, and we legislate campaign finance reform….then and only then will we have OUR America back.

Short of that, I can foresee a lot of upcoming battles….prune back the branches and the tree grows all the more strongly. We need to dig the tree up by the roots.

Yeah!!! Yes, I know we are not out of the woods yet, but it is so good to know that all of our emails and faxes to congress is making a dent and that SOMEONE is finally listening to us! After so many losses I was beginning to feel that all our emails and faxes were useless. But obviously we are making a dent. ANH-USA THANK YOU for tirelessly working on our behalf for health freedom! I am proud to be a member of The Alliance for Natural Health-USA!!!

Thank you Senators Harkin & Hatch for acting on behalf of the people. We need voices like yours to keep our health. From all of us who believe in preventive care, and leading healthy, happy lives as is our right, my husband and I thank you.

Since the guidance is still in its draft phase, a lawsuit is not yet possible until the guidance has been finalized and a party with standing can show in court that they have been harmed by the guidance. ANH is working with Jonathan Emord and others to prepare a lawsuit against the FDA at such time as it is legally possible.

I am a Utah resident (Senator Hatch’s state) and my three sons are third generation chiropractors. Supplements have always been an important part of our life and health, and the issue of natural health is of prime importance to me. Senator Hatch’s son in law is also a chiropractor in California and it pleases me no end to see him take on the giants of the opposition and effectively do what few could. Thank you to those whose voice made a difference and may we continue to fight to protect our right to natural healing.

We need idiots like this (fda) out of our lives and replaced by responsible, sympathetic human beings.. We should’t have had to write petitions concerning this matter as in it’s very nature was corruption and big pharma friendly. Let us therefore keep a big eye open so these ‘noids won’t go behind our backs and pass it behind closed doors next time.

The FDA and our government needs to stay out
Of natural products. It is another way of taxing and
Interfering with American’s business. They have
for years inforced man made medicine that has
Harmful side effects making people illl. Now they
want to restrict Natural Products for their own greed.
This must be stopped!!

Good news but in reality means nothing. The onslaught will continue. The FDA is owned lock,stock and barrel by big Pharma and they will keep coming back at this. The benefits of the citizens are never taken into account anymore, these “representatives” are not there for the people as they were originally meant to be. My guess is that eventually they will win as the apathy in this nation has gone way beyond the tipping point ( thanks to fluoride in the water ).

We need to stop this insanity. The big food company’s are well in the way to poisoning us all, and wiping out natural foods The FDA works for them and must be eliminated, GMO’s must be outlawed worldwide, The US government needs to be reined in, lobbyist outlawed Lawmakers held accountable
Evil stalkes the earth destroying at will. Attempting to control the worlds food supply is VERY BAD and must be stopped!

It’s about time the FDA tested the drugs they’re providing pharmacists that are truly killing and destroying many seniors and properly educating people about over the counter sleep aids that
have brought on an epidemic of Altzheimer’s disease instead of testing clinically the nutritional supplements people require for amnesty from their lapses in processing healthy food!

I take suppliments all the time and have avoided a heart operation because of them. I think the FDA wants to kill us so they won’t have to pay social security. Or maybe it is because the Big Drug companys depend on Seniors taking so many drugs it keeps them in business. My Doctor is amazed that I don’t take ANY drugs and am in good health. Hope to be able to continue taking my suppliments. Norma

Thank you for telling us about this information about dietary supplements. I need 43 vitamins/good oils daily to be ok with my MS/Celiac. Most of America is Celiac…but they don’t know it…tests may not work to diagnose it and doctors may not be trained it. Most people need vitamins/good oils or America will be very sick…and be a weak nation. Thanks for your awesome help!

If there is any way to add my note of thanks to Senators Orin Hatch and Tom Harkin for their intervention action I would be pleased to be informed about how to do this. Thank you for your vigilance. Yes my prayers will be supporting this journey of vigilance int he days ahead.

It would seem that haviing a larger number of our Washintin friends push together, might help show the FDA there really is a force working to protect the peolple against the FDA. Why don’t we have more than just two on our side. Ron Paul would definitly be there and I feel certain that others could be found and that doing so would be worthwhile

The FDA has too much power over our health. They are in a way telling us, you do it our way or not at all. People of today know how much health care cost and are finding easier ways to keep healthy without the high prescription cost. Even health lab cost is outrageous. A lot of us are trying to get away from chemicals. We are already getting enough in our system.

Leave a Reply

Comment Policy:ANH-USA provides a comment forum for our readers to share their constructive thoughts and criticisms about our newsletter articles and engage in civil debate with other readers. All comments are pre-moderated regardless of author. We never censor comments based on political or ideological point of view. We only remove those comments that are abusive, off-topic, use foul language, include personal attacks, or are otherwise discourteous and uncivil. Please do not post comments in ALL CAPS; on the internet this is considered "shouting."

<< DONATE to this and other campaigns:

Related Articles

This is a bill sponsored in the House by Rep. DeLauro and in the Senate by Sen. Durbin. Durbin is the arch-nemesis of natural health. But with the right amendments, this bill could actually help! Action Alert!

The supplement ban was issued based on a single unverified test, performed by a scientist who usually studies lizards, using completely inappropriate technology—and new tests show that the original testing was wrong. State-based Action Alert!

In September we offered a list of supplement companies recommended by the experts. Our readers responded with their suggestions, and after further research we have expanded our list. If readers have further thoughts and suggestions, please continue sending them in!

Use of This Website: The entire contents of this website are based upon the opinions of the Alliance for Natural Health USA (ANH-USA), unless otherwise noted. Information on this website is provided for educational purposes only; it is not intended as a substitute for medical or professional advice of any kind. It is intended as a sharing of knowledge and information from the research and experience of ANH-USA and the natural health community. Reliance upon any such opinion, advice, statement, or other information shall also be at your own risk. Neither ANH-USA, nor any of its respective agents, employees, information providers, or content providers shall be liable to any user or anyone else for any use or misuse of the information, inaccuracy, error, omission, interruption, lack of timeliness, incompleteness, deletion, defect, failure of performance, computer virus, communication line failure, alteration of, or use of any content herein, regardless of cause, or for any damages resulting therefrom.

Privacy: Reader privacy is respected. Addresses are not shared with others. For more information, please see our privacy policy.